Generic Vitrakvi Availability

Last updated on Apr 10, 2025.

Vitrakvi is a brand name of larotrectinib, approved by the FDA in the following formulation(s):

VITRAKVI (larotrectinib sulfate - capsule;oral)

• Manufacturer: BAYER HLTHCARE
  Approval date: November 26, 2018
  Strength(s): EQ 25MG BASE ^[RLD], EQ 100MG BASE ^[RLD]

VITRAKVI (larotrectinib sulfate - solution;oral)

• Manufacturer: BAYER HEALTHCARE
  Approval date: November 26, 2018
  Strength(s): EQ 20MG BASE/ML ^[RLD]

Is there a generic version of Vitrakvi available?

No. There is currently no therapeutically equivalent version of Vitrakvi available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Vitrakvi. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds
  Patent 10,005,783
  Issued: June 26, 2018
  Inventor(s): Haas Julia & Andrews Steven W. & Jiang Yutong & Zhang Gan
  Assignee(s): Array BioPharma Inc.
  

  Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or infection in a mammal.

  Patent expiration dates:

  • October 21, 2029
    
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    Patent use: METHOD OF TREATING NEUROBLASTOMA, GLIOMA, THYROID, AND BREAST CANCER SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION
• Methods of treating pediatric cancers
  Patent 10,045,991
  Issued: August 14, 2018
  Inventor(s): Cox Michael & Nanda Nisha
  Assignee(s): Loxo Oncology, Inc.
  

  A method of treating a pediatric cancer in a subject in need thereof. The method includes administering to the subject a therapeutically effective amount of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, or a pharmaceutically acceptable salt thereof, or a combination thereof.

  Patent expiration dates:

  • April 4, 2037
    
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    Patent use: METHOD OF TREATING CMN, IFS, HGG, DIPGS, PTC, SOFT TISSUE SARCOMA, AND SPINDLE CELL SARCOMA SOLID TUMORS EXHIBITING AN NTRK GENE FUSION IN A PEDIATRIC PATIENT WITH AN ORAL SOLUTION
• Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds
  Patent 10,047,097
  Issued: August 14, 2018
  Inventor(s): Haas Julia & Andrews Steven W. & Jiang Yutong & Zhang Gan
  Assignee(s): Array BioPharma Inc.
  

  Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or infection in a mammal.

  Patent expiration dates:

  • October 21, 2029
    
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    Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION AFTER SURGICAL RESECTION
• Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
  Patent 10,137,127
  Issued: November 27, 2018
  Inventor(s): Reynolds Mark & Smith Steven A.
  Assignee(s): Loxo Oncology, Inc.
  

  A liquid formulation of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutically acceptable salts thereof, or a combination thereof and the use of the liquid formulation in the treatment of pain, cancer, inflammation, and certain infectious diseases are disclosed.

  Patent expiration dates:

  • April 4, 2037
    
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    Drug product
• Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
  Patent 10,172,861
  Issued: January 8, 2019
  Inventor(s): Arrigo Alisha B. & Juengst Derrick & Shah Khalid
  Assignee(s): Array BioPharma Inc.
  

  A novel crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutical compositions containing said crystalline form and the use of said crystalline form in the treatment of pain, cancer, inflammation, neurodegenerative disease or infection are disclosed. In some embodiments, the novel crystalline form comprises a stable polymorph of (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate. The present invention is further directed to a process for the preparation of the novel crystalline form.

  Patent expiration dates:

  • November 16, 2035
    
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    Drug substance
    ✓ 
    Drug product
  • November 16, 2035
    
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    Drug substance
• Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
  Patent 10,285,993
  Issued: May 14, 2019
  Inventor(s): Arrigo Alisha B. & Juengst Derrick & Shah Khalid
  Assignee(s): Array BioPharma Inc.
  

  A novel crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutical compositions containing said crystalline form and the use of said crystalline form in the treatment of pain, cancer, inflammation, neurodegenerative disease or Trypanosoma cruzi infection are disclosed. In some embodiments, the novel crystalline form comprises a stable polymorph of (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate. The present invention is further directed to a process for the preparation of the novel crystalline form.

  Patent expiration dates:

  • November 16, 2035
    
    ✓ 
    Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION
• Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
  Patent 10,668,072
  Issued: June 2, 2020
  Inventor(s): Reynolds Mark & Smith Steven A.
  Assignee(s): Loxo Oncology, Inc.
  

  A liquid formulation of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutically acceptable salts thereof, or a combination thereof and the use of the liquid formulation in the treatment of pain, cancer, inflammation, and certain infectious diseases are disclosed.

  Patent expiration dates:

  • April 4, 2037
    
    ✓ 
    Drug product
• Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds
  Patent 10,774,085
  Issued: September 15, 2020
  Inventor(s): Haas Julia & Andrews Steven W. & Jiang Yutong & Zhang Gan
  Assignee(s): ARRAY BIOPHARMA INC.
  

  Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or Typanosoma cruzi infection in a mammal.

  Patent expiration dates:

  • October 21, 2029
    
    ✓ 
    Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION
• Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
  Patent 10,799,505
  Issued: October 13, 2020
  Inventor(s): Arrigo Alisha B. & Juengst Derrick & Shah Khalid
  Assignee(s): Array BioPharma, Inc.
  

  A novel crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutical compositions containing said crystalline form and the use of said crystalline form in the treatment of pain, cancer, inflammation, neurodegenerative disease or infection are disclosed. In some embodiments, the novel crystalline form comprises a stable polymorph of (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate. The present invention is further directed to a process for the preparation of the novel crystalline form.

  Patent expiration dates:

  • August 15, 2036
    
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    Drug substance
    ✓ 
    Drug product
  • August 15, 2036
    
    ✓ 
    Drug substance
• Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-YL)-pyrazolo[1,5-A]pyrimidin-3-YL)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
  Patent 10,813,936
  Issued: October 27, 2020
  Inventor(s): Arrigo Alisha B. & Juengst Derrick & Shah Khalid
  Assignee(s): Array BioPharma, Inc.
  

  A novel crystalline form of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutical compositions containing said crystalline form and the use of said crystalline form in the treatment of pain, cancer, inflammation, neurodegenerative disease or infection are disclosed. In some embodiments, the novel crystalline form comprises a stable polymorph of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate. The present invention is further directed to a process for the preparation of the novel crystalline form.

  Patent expiration dates:

  • November 16, 2035
    
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    Patent use: METHOD OF TREATING LUNG CANCER, UNDIFFERENTIATED SARCOMA, OR COLORECTAL CANCER THAT EXHIBITS AN NTRK GENE FUSION
• Methods of treating pediatric cancers
  Patent 11,191,766
  Issued: December 7, 2021
  Inventor(s): Cox Michael & Nanda Nisha
  Assignee(s): Loxo Oncology, Inc.
  

  A method of treating a pediatric cancer in a subject in need thereof. The method includes administering to the subject a therapeutically effective amount of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, or a pharmaceutically acceptable salt thereof, or a combination thereof.

  Patent expiration dates:

  • April 4, 2037
    
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    Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK FUSION GENE IN A PEDIATRIC PATIENT
• Methods of treatment
  Patent 11,337,967
  Issued: May 24, 2022
  Inventor(s): Srinivasan; Sundar et al.
  Assignee(s): Bow River LLC (Corona Del Mar, CA)
  

  The present disclosure provides for methods of treating a patient with a CYP3A4 substrate drug, wherein the patient is treated with posaconazole. In some embodiments, the patient stops posaconazole treatment, waits for at least 2 days, and then is treated with the CYP3A4 substrate drug as soon as it is safe to do so. In some embodiments, treatment with the CYP3A4 substrate drug is delayed for about 2-42 days after stopping posaconazole. In some embodiments, the patient is treated with a reduced dose of the CYP3A4 substrate drug for about 2-42 days.

  Patent expiration dates:

  • May 16, 2037
    
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    Patent use: TREATMENT OF SOLID TUMORS THAT HAVE A NTRK GENE FUSION THROUGH COADMINISTRATION OF LAROTRECTINIB WITH POSACONAZOLE, BY DISCONTINUING POSACONAZOLE AND WAITING 3 TO 5 OF ITS HALF-LIVES, BEFORE ADMINISTERING A FULL LAROTRECTINIB DOSE
• Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a] pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
  Patent 11,484,535
  Issued: November 1, 2022
  Inventor(s): Reynolds; Mark et al.
  Assignee(s): Loxo Oncology, Inc. (Stamford, CT)
  

  A liquid formulation of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutically acceptable salts thereof, or a combination thereof and the use of the liquid formulation in the treatment of pain, cancer, inflammation, and certain infectious diseases are disclosed.

  Patent expiration dates:

  • April 4, 2037
    
    ✓ 
    Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION
• Methods of treatment
  Patent 11,974,998
  Issued: May 7, 2024
  Inventor(s): Srinivasan; Sundar et al.
  Assignee(s): BOW RIVER LLC (Corona Del Mar, CA)
  

  The present disclosure provides for methods of treating a patient with a CYP3A4 substrate drug, wherein the patient is treated with posaconazole. In some embodiments, the patient stops posaconazole treatment, waits for at least 3 days, and then is treated with the CYP3A4 substrate drug as soon as it is safe to do so. In some embodiments, treatment with the CYP3A4 substrate drug is delayed for about 3-42 days after stopping posaconazole. In some embodiments, the patient is treated with a reduced dose of the CYP3A4 substrate drug for about 3-42 days.

  Patent expiration dates:

  • May 16, 2037
    
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    Patent use: TREATMENT OF SOLID TUMORS CHARACTERIZED BY A GENE FUSION THROUGH COADMINISTRATION OF LAROTRECTINIB WITH POSACONAZOLE, BY DISCONTINUING POSACONAZOLE AND WAITING 3 TO 5 OF ITS HALF-LIVES, BEFORE ADMINISTERING A FULL LAROTRECTINIB DOSE
• Substituted pyrazolo[1,5-a]pyrimidine compounds as Trk kinase inhibitors
  Patent 8,513,263
  Issued: August 20, 2013
  Inventor(s): Haas Julia & Andrews Steven W. & Jiang Yutong & Zhang Gan
  Assignee(s): Array BioPharma Inc.
  

  Compounds of Formula (I) in which R, R, R, R, X, Y and n have the meanings given in the specification, are inhibitors of Trk kinases and are useful in the treatment of diseases which can be treated with a Trk kinase inhibitor.

  Patent expiration dates:

  • December 23, 2029
    
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    Drug substance
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    Drug product
• Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds
  Patent 8,865,698
  Issued: October 21, 2014
  Inventor(s): Haas Julia & Andrews Steven W. & Jiang Yutong & Zhang Gan
  Assignee(s): Array BioPharma Inc.
  

  Provided herein are methods for treating pain, cancer, inflammation, neurodegenerative disease or Typanosoma cruzi infection in a mammal, which comprises administering to said mammal in need thereof a therapeutically effective amount of a compound of Formula I:

  Patent expiration dates:

  • October 21, 2029
    
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    Patent use: METHOD OF TREATING CANCEROUS SOLID TUMORS
• Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds
  Patent 9,127,013
  Issued: September 8, 2015
  Inventor(s): Haas Julia & Andrews Steven W. & Jiang Yutong & Zhang Gan
  Assignee(s): Array BioPharma, Inc.
  

  Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or infection in a mammal.

  Patent expiration dates:

  • October 21, 2029
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
• Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds
  Patent 9,447,104
  Issued: September 20, 2016
  Inventor(s): Haas Julia & Andrews Steven W. & Jiang Yutong & Zhang Gan
  Assignee(s): Array BioPharma, Inc.
  

  Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or infection in a mammal.

  Patent expiration dates:

  • October 21, 2029
    
    ✓ 
    Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION
• Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds
  Patent 9,676,783
  Issued: June 13, 2017
  Inventor(s): Haas Julia & Andrews Steven W. & Jiang Yutong & Zhang Gan
  Assignee(s): Array BioPharma, Inc.
  

  Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or Typanosoma cruzi infection in a mammal.

  Patent expiration dates:

  • October 21, 2029
    
    ✓ 
    Patent use: METHOD OF TREATING CANCEROUS SOLID TUMORS
• Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
  Patent 9,782,414
  Issued: October 10, 2017
  Inventor(s): Arrigo Alisha B. & Juengst Derrick & Shah Khalid
  Assignee(s): Array BioPharma, Inc.
  

  A novel crystalline form of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutical compositions containing said crystalline form and the use of said crystalline form in the treatment of pain, cancer, inflammation, neurodegenerative disease or infection are disclosed. In some embodiments, the novel crystalline form comprises a stable polymorph of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate. The present invention is further directed to a process for the preparation of the novel crystalline form.

  Patent expiration dates:

  • November 16, 2035
    
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    Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION IN A PEDIATRIC PATIENT
  • November 16, 2035
    
    ✓ 
    Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK FUSION GENE IN A PEDIATRIC PATIENT

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:

  • November 26, 2025 - INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC RECEPTOR TYROSINE KINASE (NTRK) GENE FUSION WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION
  • November 26, 2025 - INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY
  • November 26, 2025 - INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT HAVE NO SATISFACTORY ALTERNATIVE TREATMENTS OR THAT HAVE PROGRESSED FOLLOWING TREATMENT

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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